on writs of certiorari to the united states court of appeals for
the eleventh circuit

[June 26, 1996]

Justice Stevens
announced the judgment of the Court and delivered the opinion of the Court
with respect to Parts I, II, III, V, and VII, and an opinion with respect
to Parts IV and VI, in which Justice Kennedy, Justice Souter, and Justice
Ginsburg join.

Congress enacted the Medical Device Amendments of 1976, in the
words of the statute's preamble, "to provide for the safety and effectiveness
of medical devices intended for human use." 90 Stat. 539. The question
presented is whether that statute pre-empts a state common law negligence
action against the manufacturer of an allegedly defective medical device.
Specifically, we must consider whether Lora Lohr, who was injured when
her pacemaker failed, may rely on Florida common law to recover damages
from Medtronic, Inc., the manufacturer of the device.

Throughout our history the several States have exercised their police
powers to protect the health and safety of their citizens. Because these
are "primarily, and historically, . . . matter[s] of local concern," Hillsborough
County v. Automated Medical Laboratories, Inc., 471
U.S. 707, 719 (1985), the "States traditionally have had great latitude
under their police powers to legislate as to the protection of the lives,
limbs, health, comfort, and quiet of all persons." Metropolitan Life
Ins. Co. v. Massachusetts, 471
U.S. 724, 756 (1985) (internal quotation marks omitted).

Despite the prominence of the States in matters of public health
and safety, in recent decades the Federal Government has played an increasingly
significant role in the protection of the health of our people. Congress'
first significant enactment in the field of public health was the Food
and Drug Act of 1906, a broad prohibition against the manufacture or shipment
in interstate commerce of any adulterated or misbranded food or drug. See
34 Stat. 768; Regier, The Struggle for Federal Food and Drugs Legislation,
1 Law. & Contemp. Probs. 1 (1933). Partly in response to an ongoing
concern about radio and newspaper advertising making false therapeutic
claims for both "quack machines" and legitimate devices such as surgical
instruments and orthopedic shoes, in 1938 Congress broadened the coverage
of the 1906 Act to include misbranded or adulterated medical devices and
cosmetics. See Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), §§501,
502, 52 Stat. 1049-1051; Cavers, The Food, Drug, and Cosmetic Act of 1938:
Its Legislative History and Its Substantive Provisions, 6 Law & Contemp.
Probs. 2 (1939); H. R. Rep. No. 94-853, p. 6 (1976).

While the FDCA provided for pre-market approval of new drugs,
Cavers, 6 Law & Contemp. Probs., at 40, it did not authorize any control
over the introduction of new medical devices, see S. Rep. No. 93-670, pp.
1-2 (1974); H. R. Rep. 94-853, at 6. As technologies advanced and medicine
relied to an increasing degree on a vast array of medical equipment "[f]rom
bedpans to brainscans," [n.1]
including kidney dialysis units, artificial heart valves, and heart pacemakers, [n.2]
policymakers and the public became concerned about the increasingly severe
injuries that resulted from the failure of such devices. See generally
Finck, The Effectiveness of FDA Medical Device Regulation, 7 U. C. D. L.
Rev. 293, 297-301 (1974); H. R. Rep. 94-853, at 7.

In 1970, for example, the Dalkon Shield, an intrauterine contraceptive
device, was introduced to the American public and throughout the world.
Touted as a safe and effective contraceptive, the Dalkon Shield resulted
in a disturbingly high percentage of inadvertent pregnancies, serious infections,
and even, in a few cases, death. Id., at 8; Regulation of Medical
Devices (Intrauterine Contraceptive Devices), Hearings before a Subcommittee
of the House Committee on Government Operations, 93rd Cong., 1st Sess.
(1973). In the early 1970's, several other devices, including catheters,
artificial heart valves, defibrillators, and pacemakers (including pacemakers
manufactured by petitioner Medtronic), attracted the attention of consumers,
the FDA, and Congress as possible health risks. See Medical Device Amendments,
1973, Hearings before the Subcommittee on Health of the Senate Committee
on Labor and Public Welfare, 93rd Cong., 2d Sess., 270-361 (1973).

In response to the mounting consumer and regulatory concern, Congress
enacted the statute at issue here: the Medical Device Amendments of 1976
(MDA or Act), 90 Stat. 539. The Act classifies medical devices in three
categories based on the risk that they pose to the public. Devices that
present no unreasonable risk of illness or injury are designated Class
I and are subject only to minimal regulation by "general controls." 21
U.S.C. § 360c(a)(1)(A). Devices that are potentially more harmful
are designated Class II; although they may be marketed without advance
approval, manufacturers of such devices must comply with federal performance
regulations known as "special controls." §360c(a)(1)(B). Finally,
devices that either "present a potential unreasonable risk of illness or
injury," or which are "purported or represented to be for a use in supporting
or sustaining human life or for a use which is of substantial importance
in preventing impairment of human health," are designated Class III. §360c(a)(1)(C).
Pacemakers are Class III devices. See 21
CFR § 870.3610 (1995).

Before a new Class III device may be introduced to the market,
the manufacturer must provide the FDA with a "reasonable assurance" that
the device is both safe and effective. See 21
U.S.C. § 360e(d)(2). Despite its relatively innocuous phrasing,
the process of establishing this "reasonable assurance," which is known
as the "premarket approval," or "PMA" process, is a rigorous one. Manufacturers
must submit detailed information regarding the safety and efficacy of their
devices, which the FDA then reviews, spending an average of 1,200 hours
on each submission. Hearings before the Subcommittee on Health and the
Environment of the House Committee on Energy & Commerce, 100th Cong.,
1st Sess. (Ser. No. 100-34), p. 384 (1987) (hereinafter 1987 Hearings);
see generally Kahan, Premarket Approval Versus Premarket Notification:
Different Routes to the Same Market, 39 Food Drug Cosm. L. J. 510, 512-514
(1984).

Not all, nor even most, Class III devices on the market today
have received premarket approval because of two important exceptions to
the PMA requirement. First, Congress realized that existing medical devices
could not be withdrawn from the market while the FDA completed its PMA
analysis for those devices. The statute therefore includes a "grandfathering"
provision which allows pre-1976 devices to remain on the market without
FDA approval until such time as the FDA initiates and completes the requisite
PMA. See 21 U.S.C.
§ 360e(b)(1)(A); 21
CFR § 814.1(c)(1). [n.3]
Second, to prevent manufacturers of grandfathered devices from monopolizing
the market while new devices clear the PMA hurdle, and to ensure that improvements
to existing devices can be rapidly introduced into the market, the Act
also permits devices that are "substantially equivalent" to pre-existing
devices to avoid the PMA process. See 21
U.S.C. § 360e(b)(1)(B).

Although "substantially equivalent" Class III devices may be marketed
without the rigorous PMA review, such new devices, as well as all new Class
I and Class II devices, are subject to the requirements of §360(k).
That section imposes a limited form of review on every manufacturer intending
to market a new device by requiring it to submit a "premarket notification"
to the FDA (the process is also known as a "§510(k) process," after
the number of the section in the original Act). If the FDA concludes on
the basis of the §510(k) notification that the device is "substantially
equivalent" to a pre-existing device, it can be marketed without further
regulatory analysis (at least until the FDA initiates the PMA process for
the underlying pre-1976 device to which the new device is "substantially
equivalent"). The §510(k) notification process is by no means comparable
to the PMA process; in contrast to the 1,200 hours necessary to complete
a PMA review, the §510(k) review is completed in an average of only
20 hours. See 1987 Hearings, at 384. As one commentator noted, "[t]he attraction
of substantial equivalence to manufacturers is clear. [Section] 510(k)
notification requires little information, rarely elicits a negative response
from the FDA, and gets processed very quickly." Adler, The 1976 Medical
Device Amendments: A Step in the Right Direction Needs Another Step in
the Right Direction, 43 Food Drug Cosm. L. J. 511, 516 (1988); see also
Kahan, 39 Food Drug Cosm. L. J., at 514-519.

Congress anticipated that the FDA would complete the PMA process
for Class III devices relatively swiftly. But because of the substantial
investment of time and energy necessary for the resolution of each PMA
application, the ever increasing numbers of medical devices, and internal
administrative and resource difficulties, the FDA simply could not keep
up with the rigorous PMA process. As a result, the §510(k) premarket
notification process became the means by which most new medical devices--including
Class III devices--were approved for the market. In 1983, for instance,
a House Report concluded that nearly 1,000 of approximately 1,100 Class
III devices that had been introduced to the market since 1976 were admitted
as "substantial equivalents" and without any PMA review. See Medical
Device Regulation: The FDA's Neglected Child (Committee Print compiled
for the Subcommittee on Oversight and Investigations of the House Committee
on Energy and Commerce), Comm. Print 98-F, p. 34 (1983). This lopsidedness
has apparently not evened out; despite an increasing effort by the FDA
to consider the safety and efficacy of substantially equivalent devices,
the House reported in 1990 that 80% of new Class III devices were being
introduced to the market through the §510(k) process and without PMA
review. H. R. Rep. No. 101-808, p. 14 (1990); see also D. Kessler, S. Pape,
& D. Sundwall, The Federal Regulation of Medical Devices, 317 New England
J. Med. 357, 359 (1987) (55 §510(k) notifications are filed for each
PMA application; average FDA response to §510(k) notification is one
fifth the response time to a PMA). [n.4]

As have so many other medical device manufacturers, petitioner Medtronic
took advantage of §510(k)'s expedited process in October of 1982,
when it notified FDA that it intended to market its Model 4011 pacemaker
lead as a device that was "substantially equivalent" to devices already
on the market. (The lead is the portion of a pacemaker that transmits the
heartbeat steadying electrical signal from the "pulse generator" to the
heart itself.) On November 30, 1982, the FDA found that the model was "substantially
equivalent to devices introduced into interstate commerce" prior to the
effective date of the Act, and advised Medtronic that it could therefore
market its device subject only to the general control provisions of the
Act, which could be found in the Code of Federal Regulations. See Respondent's
Memorandum in Support of Motion for Summary Judgment in No. 93-482 (MD
Fla., Nov. 1, 1993), Exh. A to Exh. 1 (Declaration of Charles H. Swanson)
(hereinafter FDA Substantial Equivalence Letter). The agency emphasized,
however, that this determination should not be construed as an endorsement
of the pacemaker lead's safety. Ibid.

Cross petitioner Lora Lohr is dependent on pacemaker technology
for the proper functioning of her heart. In 1987 she was implanted with
a Medtronic pacemaker equipped with one of the company's Model 4011 pacemaker
leads. On December 30, 1990, the pacemaker failed, allegedly resulting
in a "complete heart block" that required emergency surgery. According
to her physician, a defect in the lead was the likely cause of the failure.

In 1993 Lohr and her husband filed this action in a Florida state
court. Their complaint contained both a negligence count and a strict liability
count. The negligence count alleged a breach of Medtronic's "duty to use
reasonable care in the design, manufacture, assembly, and sale of the subject
pacemaker" in several respects, including the use of defective materials
in the lead and a failure to warn or properly instruct the plaintiff or
her physicians of the tendency of the pacemaker to fail, despite knowledge
of other earlier failures. Complaint ¶5. The strict liability count
alleged that the device was in a defective condition and unreasonably dangerous
to foreseeable users at the time of its sale. Id., ¶11. ( A
third count alleging breach of warranty was dismissed for failure to state
a claim under Florida law.)

Medtronic removed the case to Federal District Court, where it
filed a motion for summary judgment arguing that both the negligence and
strict liability claims were pre-empted by 21
U.S.C. § 360k(a). That section, which is at the core of the dispute
between the parties in this case, provides:

"§ 360k. State and local requirements
respecting devices

"(a) General rule

"Except as provided in subsection (b) of this section, no State
or political subdivision of a State may establish or continue in effect
with respect to a device intended for human use any requirement--

"(1) which is different from, or in addition to, any requirement
applicable under this chapter to the device, and

"(2) which relates to the safety or effectiveness of the device
or to any other matter included in a requirement applicable to the device
under this chapter." [n.5]

The District Court initially denied Medtronic's motion, finding nothing
in the statute to support the company's argument that the MDA entirely
exempted from liability a manufacturer who had allegedly violated the FDA's
regulations. See App. to Pet. for Cert. 5d. Not long after that decision,
however, the United States Court of Appeals for the Eleventh Circuit concluded
that §360k required pre-emption of at least some common law claims
brought against the manufacturer of a medical device. See Duncan
v. Iolab Corp., 12 F. 3d 194 (1994). After reconsidering its ruling
in light of Duncan, the District Court reversed its earlier decision
and dismissed the Lohrs' entire complaint.

The Court of Appeals reversed in part and affirmed in part. 56
F. 3d 1335 (CA11 1995). Rejecting the Lohrs' broadest submission, it first
decided that "common law actions are state requirements within the meaning
of §360k(a)." Id., at 1342. It next held that pre-emption could
not be avoided by merely alleging that the negligence flowed from a violation
of federal standards. Id., at 1343. Then, after concluding that
the term "requirements" in §360k(a) was unclear, it sought guidance
from FDA's regulations regarding pre-emption. Those regulations provide
that a state requirement is not pre-empted unless the FDA has established
" `specific requirements applicable to a particular device.' " Id.,
at 1344 (citing 21
CFR § 808.1(d) (1995)). Under these regulations, the court concluded,
it was not necessary that the federal regulation specifically deal with
pacemakers, but only that the federal requirement "should, in some way,
be `restricted by nature' to a particular process, procedure, or device
and should not be completely open ended," 56 F. 3d, at 1346, and that the
specific device at issue should be subject to its requirements.

Under this approach, the Court concluded that the Lohrs' negligent
design claims were not pre-empted. It rejected Medtronic's argument that
the FDA's finding of "substantial equivalence" had any significance with
respect to the pacemaker's safety, or that the FDA's continued surveillance
of the device constituted a federal "requirement" that its design be maintained.
Id., at 1347-1349. On the other hand, it concluded that the negligent
manufacturing and failure to warn claims were pre-empted by FDA's general
"good manufacturing practices" regulations, which establish general requirements
for most steps in every device's manufacture, see id., at 1350;
21
CFR §§ 820.20-820.198 (1995), and by the FDA labeling regulations,
which require devices to bear various warnings, see 56 F. 3d, at 1350-1351;
21
CFR § 801.109 (1995). The Court made a parallel disposition of
the strict liability claims, holding that there was no pre-emption insofar
as plaintiffs alleged an unreasonably dangerous design, but they could
not revive the negligent manufacturing or failure to warn claims under
a strict liability theory. 56 F. 3d, at 1351-1352.

Medtronic filed a petition for certiorari seeking review of the
Court of Appeals' decision insofar as it affirmed the District Court and
the Lohrs filed a cross petition seeking review of the judgment insofar
as it upheld the pre-emption defense. Because the Courts of Appeals are
divided over the extent to which state common law claims are pre-empted
by the MDA, [n.6]
we granted both petitions. 516 U. S. ___ (1996).

As in Cipollone v. Liggett Group, Inc., 505
U.S. 504 (1992), we are presented with the task of interpreting a statutory
provision that expressly pre-empts state law. While the pre-emptive language
of §360k(a) means that we need not go beyond that language to determine
whether Congress intended the MDA to pre-empt at least some state law,
see id., at 517, we must nonetheless "identify the domain expressly
pre-empted" by that language. Ibid. Although our analysis of the
scope of the pre-emption statute must begin with its text, see Gade
v. National Solid Wastes Management Assn., 505
U.S. 88, 111 (1992) (Kennedy, J., concurring in part and concurring
in judgment), our interpretation of that language does not occur in a contextual
vacuum. Rather, that interpretation is informed by two presumptions about
the nature of pre-emption. See ibid.

First, because the States are independent sovereigns in our federal
system, we have long presumed that Congress does not cavalierly pre-empt
state law causes of action. In all pre-emption cases, and particularly
in those in which Congress has "legislated . . . in a field which the States
have traditionally occupied," Rice v. Santa Fe Elevator Corp.,
331
U.S. 218, 230 (1947), we "start with the assumption that the historic
police powers of the States were not to be superseded by the Federal Act
unless that was the clear and manifest purpose of Congress." Id.,
at 230; Hillsborough Cty., 471 U. S., at 715-716; cf. Fort Halifax
Packing Co. v. Coyne, 482
U.S. 1, 22 (1987). Although dissenting
Justices have argued that this assumption should apply only to the question
whether Congress intended any pre-emption at all, as opposed to questions
concerning the scope of its intended invalidation of state law,
see Cipollone, 505 U. S., at 545-546 (Scalia, J., concurring in
judgment in part, and dissenting in part), we used a "presumption against
the pre-emption of state police power regulations" to support a narrow
interpretation of such an express command in Cipollone. Id.,
at 518, 523. That approach is consistent with both federalism concerns
and the historic primacy of state regulation of matters of health and safety.

Second, our analysis of the scope of the statute's pre-emption
is guided by our oft repeated comment, initially made in Retail Clerks
v. Schermerhorn, 375
U.S. 96, 103 (1963), that "[t]he purpose of Congress is the ultimate
touchstone" in every pre-emption case. See, e.g., Cipollone,
505 U. S., at 516; Gade, 505 U. S., at 96; Malone v. White
Motor Corp., 435
U.S. 497, 504 (1978). As a result, any understanding of the scope of
a pre-emption statute must rest primarily on "a fair understanding of congressional
purpose." Cipollone, 505 U. S., at 530, n. 27 (opinion of Stevens,
J.). Congress' intent, of course, primarily is discerned from the language
of the pre-emption statute and the "statutory framework" surrounding it.
Gade, 505 U. S., at 111 (Kennedy, J., concurring in part and concurring
in judgment). Also relevant, however, is the "structure and purpose of
the statute as a whole," id., at 98 (opinion of O'Connor, J.), as
revealed not only in the text, but through the reviewing court's reasoned
understanding of the way in which Congress intended the statute and its
surrounding regulatory scheme to affect business, consumers, and the law.

With these considerations in mind, we turn first to a consideration
of petitioner Medtronic's claim that the Court of Appeals should have found
the entire action pre-empted and then to the merits of the Lohrs' cross
petition.

In its petition, Medtronic argues that the Court of Appeals erred by
concluding that the Lohrs' claims alleging negligent design were not pre-empted
by 21 U.S.C. §
360k(a). That section provides that "no State or political subdivision
of a State may establish or continue in effect with respect to a device
intended for human use any requirement (1) which is different from, or
in addition to, any requirement applicable under this chapter to the device,
and (2) which relates to the safety or effectiveness of the device or to
any other matter included in a requirement applicable to the device under
this chapter." Medtronic suggests that any common law cause of action is
a "requirement" which alters incentives and imposes duties "different from,
or in addition to" the generic federal standards that the FDA has promulgated
in response to mandates under the MDA. In essence, the company argues that
the plain language of the statute pre-empts any and all common law claims
brought by an injured plaintiff against a manufacturer of medical devices.

Medtronic's argument is not only unpersuasive, it is implausible.
Under Medtronic's view of the statute, Congress effectively precluded state
courts from affording state consumers any protection from injuries resulting
from a defective medical device. Moreover, because there is no explicit
private cause of action against manufacturers contained in the MDA, and
no suggestion that the Act created an implied private right of action,
Congress would have barred most, if not all, relief for persons injured
by defective medical devices. [n.7]
Medtronic's construction of §360k would therefore have the perverse
effect of granting complete immunity from design defect liability to an
entire industry that, in the judgment of Congress, needed more stringent
regulation in order "to provide for the safety and effectiveness of medical
devices intended for human use," 90 Stat. 539 (preamble to Act). It is,
to say the least, "difficult to believe that Congress would, without comment,
remove all means of judicial recourse for those injured by illegal conduct,"
Silkwood v. Kerr McGee Corp., 464
U.S. 238, 251 (1984), and it would take language much plainer than
the text of §360k to convince us that Congress intended that result.

Furthermore, if Congress intended to preclude all common law causes
of action, it chose a singularly odd word with which to do it. The statute
would have achieved an identical result, for instance, if it had precluded
any "remedy" under state law relating to medical devices. "Requirement"
appears to presume that the State is imposing a specific duty upon the
manufacturer, and although we have on prior occasions concluded that a
statute pre-empting certain state "requirements" could also pre-empt common
law damages claims, see Cipollone, 505 U. S., at 521-522 (opinion
of Stevens, J.), that statute did not sweep nearly as broadly as Medtronic
would have us believe that this statute does.

The pre-emptive statute in Cipollone[n.8]
was targeted at a limited set of state requirements--those "based on smoking
and health"--and then only at a limited subset of the possible applications
of those requirements--those involving the "advertising or promotion of
any cigarettes the packages of which are labeled in conformity with the
provisions of" the federal statute. See id., at 515. In that context,
giving the term "requirement" its widest reasonable meaning did not have
nearly the pre-emptive scope nor the effect on potential remedies that
Medtronic's broad reading of the term would have in this case. The Court
in Cipollone held that the petitioner in that case was able to maintain
some common law actions using theories of the case that did not run afoul
of the pre-emption statute. See id., at 524-530. Here, however,
Medtronic's sweeping interpretation of the statute would require far greater
interference with state legal remedies, producing a serious intrusion into
state sovereignty while simultaneously wiping out the possibility of remedy
for the Lohrs' alleged injuries. [n.9]
Given the ambiguities in the statute and the scope of the preclusion that
would occur otherwise, we cannot accept Medtronic's argument that by using
the term-requirement," Congress clearly signaled its intent to deprive
States of any role in protecting consumers from the dangers inherent in
many medical devices.

Other differences between this statute and the one in Cipollone
further convince us that when Congress enacted §360k, it was primarily
concerned with the problem of specific, conflicting State statutes and
regulations rather than the general duties enforced by common law actions.
Unlike the statute at issue in Cipollone, §360k refers to "requirements"
many times throughout its text. In each instance, the word is linked with
language suggesting that its focus is device specific enactments of positive
law by legislative or administrative bodies, not the application of general
rules of common law by judges and juries. For instance, subsections (a)(2)
and (b) of the statute [n.10]
also refer to "requirements"--but those "requirements" refer only to statutory
and regulatory law that exists pursuant to the MDA itself, suggesting that
the pre-empted "requirements" established or continued by States also refer
primarily to positive enactments of state law. Moreover, in subsection
(b) the FDA is given authority to exclude certain "requirements" from the
scope of the pre-emption statute. Of the limited number of "exemptions"
from pre-emption that the FDA has granted, none even remotely resemble
common law claims. [n.11]

An examination of the basic purpose of the legislation as well as its
history entirely supports our rejection of Medtronic's extreme position.
The MDA was enacted "to provide for the safety and effectiveness of medical
devices intended for human use." 90 Stat. 539. Medtronic asserts that the
Act was also intended, however, to-protect innovations in device technology
from being `stifled by unnecessary restrictions,' " Brief for Petitioners
in No. 95-754, p. 3 (citing H. R. Rep. 94-853, at 12), and that this interest
extended to the pre-emption of common law claims. While the Act certainly
reflects some of these concerns, [n.12]
the legislative history indicates that any fears regarding regulatory burdens
were related more to the risk of additional federal and state regulation
rather than the danger of preexisting duties under common law. See, e.g.,
122 Cong. Rec. 5850 (Mar. 9, 1976) (statement of Rep. Collins) (opposing
further "redundant and burdensome Federal requirements"); id., at
5855 (discussing efforts taken in MDA to protect small businesses from
the additional requirements of the Act). Indeed, nowhere in the materials
relating to the Act's history have we discovered a reference to a fear
that product liability actions would hamper the development of medical
devices. To the extent that Congress was concerned about protecting the
industry, that intent was manifested primarily through fewer substantive
requirements under the Act, not the pre-emption provision; furthermore,
any such concern was far outweighed by concerns about the primary issue
motivating the MDA's enactment: the safety of those who use medical devices.

The legislative history also confirms our understanding that §360(k)
simply was not intended to pre-empt most, let alone all, general common
law duties enforced by damages actions. There is, to the best of our knowledge,
nothing in the hearings, the committee reports, or the debates suggesting
that any proponent of the legislation intended a sweeping pre-emption of
traditional common law remedies against manufacturers and distributors
of defective devices. If Congress intended such a result, its failure even
to hint at it is spectacularly odd, particularly since Members of both
Houses were acutely aware of ongoing product liability litigation. [n.13]
Along with the less than precise language of §360k(a), that silence
surely indicates that at least some common law claims against medical device
manufacturers may be maintained after the enactment of the MDA.

Medtronic asserts several specific reasons why, even if §360k does
not pre-empt all common law claims, it at least pre-empts the Lohrs' claims
in this case. In contrast, the Lohrs argue that their entire complaint
should survive a reasonable evaluation of the pre-emptive scope of §360k(a).
First, the Lohrs claim that the Court of Appeals correctly held that their
negligent design claims were not pre-empted because the §510(k) premarket
notification process imposes no "requirement" on the design of Medtronic's
pacemaker. Second, they suggest that even if the FDA's general rules regulating
manufacturing practices and labeling are "requirements" that pre-empt different
state requirements, §360k(a) does not pre-empt state rules that
merely duplicate some or all of those federal requirements. Finally, they
argue that because the State's general rules imposing common law duties
upon Medtronic do not impose a requirement "with respect to a device,"
they do not conflict with the FDA's general rules relating to manufacturing
and labeling and are therefore not pre-empted.

Design Claim

The Court of Appeals concluded that the Lohrs' defective design
claims were not pre-empted because the requirements with which the company
had to comply were not sufficiently concrete to constitute a pre-empting
federal requirement. Medtronic counters by pointing to the FDA's determination
that Model 4011 is "substantially equivalent" to an earlier device as well
as the agency's continuing authority to exclude the device from the market
if its design is changed. These factors, Medtronic argues, amount to a
specific, federally enforceable design requirement that cannot be affected
by state law pressures such as those imposed on manufacturers subject to
product liability suits.

The company's defense exaggerates the importance of the §510(k)
process and the FDA letter to the company regarding the pacemaker's substantial
equivalence to a grandfathered device. As the court below noted, "[t]he
510(k) process is focused on equivalence, not safety." 56F. 3d,
at 1348. As a result, "substantial equivalence determinations provide little
protection to the public. These determinations simply compare a post-1976
device to a pre-1976 device to ascertain whether the later device is no
more dangerous and no less effective than the earlier device. If the earlier
device poses a severe risk or is ineffective, then the later device may
also be risky or ineffective." Adler, 43 Food Drug Cosm. L. J., at 516.
The design of the Model 4011, as with the design of pre-1976 and other
"substantially equivalent" devices, has never been formally reviewed under
the MDA for safety or efficacy.

The FDA stressed this basic conclusion in its letter to Medtronic
finding the 4011 lead "substantially equivalent" to devices already on
the market. That letter only required Medtronic to comply with "general
standards"--the lowest level of protection "applicable to all medical devices,"
and including "listing of devices, good manufacturing practices, labeling,
and the misbranding and adulteration provisions of the Act." It explicitly
warned Medtronic that the letter did "not in any way denote official FDA
approval of your device," and that "[a]ny representation that creates an
impression of official approval of this device because of compliance with
the premarket notification regulations is misleading and constitutes misbranding."
FDA Substantial Equivalence Letter.

Thus, even though the FDA may well examine §510(k) applications
for Class III devices (as it examines the entire medical device industry)
with a concern for the safety and effectiveness of the device, see Brief
for Petitioner in No. 95-754, pp. 22-26, it did not "require" Medtronics'
pacemaker to take any particular form for any particular reason; the agency
simply allowed the pacemaker, as a device substantially equivalent to one
that existed before 1976, to be marketed without running the gauntlet of
the PMA process. In providing for this exemption to PMA review, Congress
intended merely to give manufacturers the freedom to compete, to a limited
degree, with and on the same terms as manufacturers of medical devices
that existed prior to 1976. [n.14]
There is no suggestion in either the statutory scheme or the legislative
history that the §510(k) exemption process was intended to do anything
other than maintain the status quo with respect to the marketing of existing
medical devices and their substantial equivalents. That status quo included
the possibility that the manufacturer of the device would have to defend
itself against state law claims of negligent design. Given this background
behind the "substantial equivalence" exemption, the fact that "[t]he purpose
of Congress is the ultimate touchstone" in every pre-emption case, 505
U. S., at 516 (internal quotation marks and citations omitted), and the
presumption against pre-emption, the Court of Appeals properly concluded
that the "substantial equivalence" provision did not pre-empt the Lohrs'
design claims.

Identity of Requirements Claims

The Lohrs next suggest that even if "requirements" exist with
respect to the manufacturing and labeling of the pacemaker, and even if
we can also consider state law to impose a "requirement" under the Act,
the state requirement is not pre-empted unless it is "different from, or
in addition to," the federal requirement. §360k(a)(1). Although the
precise contours of their theory of recovery have not yet been defined
(the pre-emption issue was decided on the basis of the pleadings), it is
clear that the Lohrs' allegations may include claims that Medtronic has,
to the extent that they exist, violated FDA regulations. At least these
claims, they suggest, can be maintained without being pre-empted by §360k,
and we agree.

Nothing in §360k denies Florida the right to provide a traditional
damages remedy for violations of common law duties when those duties parallel
federal requirements. Even if it may be necessary as a matter of Florida
law to prove that those violations were the result of negligent conduct,
or that they created an unreasonable hazard for users of the product, such
additional elements of the state law cause of action would make the state
requirements narrower, not broader, than the federal requirement. While
such a narrower requirement might be "different from" the federal rules
in a literal sense, such a difference would surely provide a strange reason
for finding pre-emption of a state rule insofar as it duplicates the federal
rule. The presence of a damages remedy does not amount to the additional
or different "requirement" that is necessary under the statute; rather,
it merely provides another reason for manufacturers to comply with identical
existing "requirements" under federal law.

The FDA regulations interpreting the scope of §360k's pre-emptive
effect support the Lohrs' view, and our interpretation of the pre-emption
statute is substantially informed by those regulations. The different views
expressed by the Courts of Appeals regarding the appropriate scope of federal
pre-emption under §360k demonstrate that the language of that section
is not entirely clear. In addition, Congress has given the FDA a unique
role in determining the scope of §360k's pre-emptive effect. Unlike
the statute construed in Cipollone, for instance, pre-emption under
the MDA does not arise directly as a result of the enactment of the statute;
rather, in most cases a state law will be pre-empted only to the extent
that the FDA has promulgated a relevant federal "requirement." Because
the FDA is the federal agency to which Congress has delegated its authority
to implement the provisions of the Act, [n.15]
the agency is uniquely qualified to determine whether a particular form
of state law "stands as an obstacle to the accomplishment and execution
of the full purposes and objectives of Congress," Hines v. Davidowitz,
312
U.S. 52, 67 (1941), and, therefore, whether it should be pre-empted.
For example, Congress explicitly delegated to the FDA the authority to
exempt state regulations from the pre-emptive effect of the MDA--an authority
that necessarily requires the FDA to assess the pre-emptive effect that
the Act and its own regulations will have on state laws. See §360k(b).
FDA regulations implementing that grant of authority establish a process
by which States or other individuals may request an advisory opinion from
the FDA regarding whether a particular state requirement is pre-empted
by the statute. See 21
CFR § 808.5 (1995). The ambiguity in the statute--and the congressional
grant of authority to the agency on the matter contained within it--provide
a "sound basis," post, at 2, for giving substantial weight to the
agency's view of the statute. See Chevron U. S. A. Inc. v. Natural
Resources Defense Council, Inc.,467
U.S. 837 (1984); Hillsborough Cty., 471 U. S., at 714 (considering
FDA understanding of pre-emptive effect of its regulations "dispositive").

The regulations promulgated by the FDA expressly support the conclusion
that §360k "does not preempt State or local requirements that are
equal to, or substantially identical to, requirements imposed by or under
the act." 21
CFR § 808.1(d)(2) (1995); see also §808.5(b)(1)(i). [n.16]
At this early stage in the litigation, there was no reason for the Court
of Appeals to preclude altogether the Lohrs' manufacturing and labeling
claims to the extent that they rest on claims that Medtronic negligently
failed to comply with duties "equal to, or substantially identical to,
requirements imposed" under federal law.

Manufacturing and Labeling Claims

Finally, the Lohrs suggest that with respect to the manufacturing
and labeling claims, the Court of Appeals should have rejected Medtronic's
pre-emption defense in full. The Court of Appeals believed that these claims
would interfere with the consistent application of general federal regulations
governing the labeling and manufacture of all medical devices, and therefore
concluded that the claims were pre-empted altogether.

The requirements identified by the Court of Appeals include labeling
regulations which require manufacturers of every medical device, with a
few limited exceptions, to include with the device a label containing "information
for use, . . . and any relevant hazards, contraindications, side effects,
and precautions." 21
CFR §§ 801.109(b) and (c) (1995). Similarly, manufacturers
are required to comply with "Good Manufacturing Practices," or "GMP's,"
which are set forth in 32 sections and less than 10 pages in the Code of
Federal Regulations. [n.17]
In certain circumstances, the Court of Appeals recognized, the FDA will
enforce these general requirements against manufacturers that violate them.
See 56 F. 3d, at 1350-1351.

While admitting that these requirements exist, the Lohrs suggest
that their general nature simply does not pre-empt claims alleging that
the manufacturer failed to comply with other duties under state common
law. In support of their claim, they note that §360k(a)(1) expressly
states that a federal requirement must be "applicable to the device" in
question before it has any pre-emptive effect. Because the labeling and
manufacturing requirements are applicable to a host of different devices,
they argue that they do not satisfy this condition. They further argue
that because only state requirements "with respect to a device" may be
pre-empted, and then only if the requirement "relates to the safety or
effectiveness of the device or to any other matter included in a requirement
applicable to the device," section 360k(a) mandates pre-emption only where
there is a conflict between a specific state requirement and a federal
requirement "applicable to" the same device.

The Lohrs' theory is supported by the FDA regulations, which provide
that state requirements are pre-empted "only" when the FDA has established
"specific counterpart regulations or . . . other specific requirements
applicable to a particular device." 21
CFR § 808.1(d) (1995). [n.18]
They further note that the statute is not intended to pre-empt "State or
local requirements of general applicability where the purpose of the requirement
relates either to other products in addition to devices . . . or to unfair
trade practices in which the requirements are not limited to devices."
§808.1(d)(1). The regulations specifically provide, as examples of
permissible general requirements, that general electrical codes and the
Uniform Commercial Code warranty of fitness would not be pre-empted. See
ibid. The regulations even go so far as to state that §360k(a)
generally "does not preempt a state or local requirement prohibiting the
manufacture of adulterated or misbranded devices" unless "such a prohibition
has the effect of establishing a substantive requirement for a specific
device." §808.1(d)(6)(ii). Furthermore, under its authority to grant
exemptions to the pre-emptive effect of §360k(a), the FDA has never
granted, nor, to the best of our knowledge, even been asked to consider
granting, an exemption for a state law of general applicability; all 22
existing exemptions apply to excruciatingly specific state requirements
regarding the sale of hearing aids. See §§808.53-808.101.

Although we do not believe that this statutory and regulatory
language necessarily precludes "general" federal requirements from ever
pre-empting state requirements, or "general" state requirements from ever
being pre-empted, see Part VI, infra, it is impossible to ignore
its overarching concern that pre-emption occur only where a particular
state requirement threatens to interfere with a specific federal interest.
State requirements must be "with respect to" medical devices and "different
from, or in addition to" federal requirements. State requirements must
also relate "to the safety or effectiveness of the device or to any other
matter included in a requirement applicable to the device," and the regulations
provide that state requirements of "general applicability" are not pre-empted
except where they have "the effect of establishing a substantive requirement
for a specific device." Moreover, federal requirements must be "applicable
to the device" in question, and, according to the regulations, pre-empt
state law only if they are "specific counterpart regulations" or "specific"
to a "particular device." The statute and regulations, therefore, require
a careful comparison between the allegedly pre-empting federal requirement
and the allegedly pre-empted state requirement to determine whether they
fall within the intended pre-emptive scope of the statute and regulations. [n.19]

Such a comparison mandates a conclusion that the Lohrs' common law claims
are not pre-empted by the federal labeling and manufacturing requirements.
The generality of those requirements make this quite unlike a case in which
the Federal Government has weighed the competing interests relevant to
the particular requirement in question, reached an unambiguous conclusion
about how those competing considerations should be resolved in a particular
case or set of cases, and implemented that conclusion via a specific mandate
on manufacturers or producers. Rather, the federal requirements reflect
important but entirely generic concerns about device regulation generally,
not the sort of concerns regarding a specific device or field of device
regulation which the statute or regulations were designed to protect from
potentially contradictory state requirements.

Similarly, the general state common law requirements in this case were
not specifically developed "with respect to" medical devices. Accordingly,
they are not the kinds of requirements that Congress and the FDA feared
would impede the ability of federal regulators to implement and enforce
specific federal requirements. The legal duty that is the predicate for
the Lohrs' negligent manufacturing claim is the general duty of every manufacturer
to use due care to avoid foreseeable dangers in its products. Similarly,
the predicate for the failure to warn claim is the general duty to inform
users and purchasers of potentially dangerous items of the risks involved
in their use. These general obligations are no more a threat to federal
requirements than would be a state law duty to comply with local fire prevention
regulations and zoning codes, or to use due care in the training and supervision
of a workforce. These state requirements therefore escape pre-emption,
not because the source of the duty is a judge made common law rule, but
rather because their generality leaves them outside the category of requirements
that §360k envisioned to be "with respect to" specific devices such
as pacemakers. As a result, none of the Lohrs' claims based on allegedly
defective manufacturing or labeling are pre-empted by the MDA.

In their cross petition, the Lohrs present
a final argument, suggesting that common law duties are never "requirements"
within the meaning of §360k and that the statute therefore never pre-empts
common law actions. The Lohrs point out that our holding in Cipollone
is not dispositive of this issue, for as Part IV, supra, suggests,
there are significant textual and historical differences between the Cipollone
statute and §360k, and the meaning of words must always be informed
by the environment within which they are situated. We do not think that
the issue is resolved by the FDA regulation suggesting that §360k
is applicable to those requirements "having the force and effect of law"
that are "established by . . . court decision," 21
CFR § 808.1(b) (1995); that reference, it appears, was intended
to refer to court decisions construing state statutes or regulations.
See 42 Fed. Reg. 30383, 30385 (June 14, 1977); Brief for Petitioners in
No. 95-886, at 26, n. 7.

Nevertheless, we do not respond directly to this argument for
two reasons. First, since none of the Lohrs' claims is pre-empted in this
case, we need not resolve hypothetical cases that may arise in the future.
Second, given the critical importance of device specificity in our (and
the FDA's) construction of §360k, it is apparent that few, if any,
common law duties have been pre-empted by this statute. It will be rare
indeed for a court hearing a common law cause of action to issue a decree
that has "the effect of establishing a substantive requirement for a specific
device." 21
CFR § 808.1(d)(6)(ii) (1995). Until such a case arises, we see
no need to determine whether the statute explicitly pre-empts such a claim.
Even then, the issue may not need to be resolved if the claim would also
be pre-empted under conflict pre-emption analysis, see Freightliner
Corp. v. Myrick, 514 U. S. ___, ___ (1995) (slip op., at 7-8).

Accordingly, the judgment of the Court of Appeals is reversed insofar
as it held that any of the claims were pre-empted and affirmed insofar
as it rejected the pre-emption defense. The case is remanded for further
proceedings.

It is so ordered.

Notes

1 Medical
Device Regulation: The FDA's Neglected Child (Committee Print compiled
for the Subcommittee on Oversight and Investigations of the House Committee
on Energy and Commerce), Comm. Print 98-F, p. 1 (1983).

3 The
FDA has not yet initiated nor suggested the initiation of a PMA process
for pacemakers or most other grandfathered devices. But see 60 Fed. Reg.
41984, 41986 (1995) (pursuant to Safe Medical Devices Act of 1990, 104
Stat. 4511, calling for submission of information by February 1997 which
may lead the FDA to reclassify or initiate PMA process at some time in
the future for implantable pacemaker pulse generators and lead adapters).

4 In
1990, Congress enacted amendments to the MDA which were designed to reduce
the FDA's reliance on the §510(k) process while continuing to ensure
that particularly risky devices received full PMA review. See Safe Medical
Devices Act of 1990.

5 Subsection
(b) of the statute authorizes the FDA to grant exemptions to state requirements
that would otherwise be pre-empted by subsection (a). Section
360k(b) provides:

"(b) Exempt requirements

"Upon application of a State or a political subdivision thereof,
the Secretary may, by regulation promulgated after notice and opportunity
for an oral hearing, exempt from subsection (a) of this section, under
such conditions as may be prescribed in such regulation, a requirement
of such State or political subdivision applicable to a device intended
for human use if--

"(1) the requirement is more stringent than a requirement under
this chapter which would be applicable to the device if an exemption were
not in effect under this subsection; or

"(2) the requirement--

"(A) is required by compelling local conditions, and

"(B) compliance with the requirement would not cause the device
to be in violation of any applicable requirement under this chapter."

To carry out this grant of authority, the FDA has issued regulations
under the statute which both construe the scope of §360k(a) and address
the instances in which the FDA will grant exemptions to its pre-emptive
effect. See 21
CFR § 808.1 (1995); infra, n. 18.

We note that although it is the FDA that exercises this authority,
the Act gives that authority directly to the Secretary of Health and Human
Services, who subsequently delegated her authority to the FDA. See, e.g.,
21 U.S.C. §
360k(b) ("the Secretary may" exempt state requirements), §321(d)
("Secretary" defined as "the Secretary of Health and Human Services").
Under the FDCA, the Secretary is vested with "[t]he authority to promulgate
regulations for the efficient enforcement of" the Act. 21
U.S.C. § 371(a).

7 The
FDA's authority to require manufacturers to recall, replace, or refund
defective devices is of little use to injured plaintiffs, since there is
no indication that the right is available to private parties, the remedy
would not extend to recovery for compensatory damages, and the authority
is rarely invoked, if at all. See Adler, The 1976 Medical Device Amendments:
A Step in the Right Direction Needs Another Step in the Right Direction,
43 Food Drug Cosm. L. J. 511, 526-527 (1988).

8 There
were actually two pre-emptive statutes at issue: The first, enacted in
1965, provided that "[n]o statement relating to smoking and health . .
. shall be required" on any cigarette package or in any cigarette advertising.
See Cipollone v. Liggett Group, Inc., 505 U. S., at 514.
That provision, the Court concluded, did not pre-empt any of the petitioner's
common law claims. Id., at 518-520. In 1969, Congress superseded
the 1965 pre-emption statute with part of the Public Health Cigarette Smoking
Act of 1969, which provided that "[n]o requirement or prohibition based
on smoking and health shall be imposed under State law with respect to
the advertising or promotion of any cigarettes the packages of which are
labeled in conformity with the provisions of this Act." Id., at
515. The bulk of Cipollone's analysis involved this later statute;
unless otherwise stated, it is this statute to which we refer in subsequent
references to the pre-emptive statute in Cipollone.

9 Unlike
§360k, the pre-emptive effect of the statute in Cipollone was
not dependent on the issuance of any agency regulations. The territory
exclusively occupied by federal law was defined in the text of the statute
itself; that text specified the precise warning to smokers that Congress
deemed both necessary and sufficient. In the MDA, no such specifics exist
until the FDA provides them. See also infra, at 24 (reliance on
the FDA's interpretation of §360k warranted, inter alia, because
of the FDA's role in the administration of §360k). Moreover, the statute
in Cipollone was clearly intended to have a broader pre-emptive
effect than its 1965 predecessor. See 505 U. S., at 515, 520-521.

11 All
22 exemptions at 21
CFR §§ 808.53-808.101 (1995) are exemptions for state statutes
and regulations regarding the sale of hearing aids.

12 Special
statutory exemptions, for example, permit the FDA (with various oversight
provisions) to allow investigative, experimental devices to be used in
commerce without either PMA review or "substantial equivalence." See 21
U.S.C. § 360j(g); 21 CFR pt. 813 (1995). Moreover, the very existence
of the pre-emption statute demonstrates some concern that competing state
requirements may unduly interfere with the market for medical devices.

13 Furthermore,
if Congress had intended the MDA to work this dramatic change in the availability
of state law remedies, one would expect some reference to that change in
the extensive contemporary reviews of the legislation. We have been able
to find no such reference. See, e.g., Lesparre, Industry Spokesman
Comments on Medical Device Amendments of 1976, 50 Hospitals 99, 103 (Sept.
16, 1976); A. Levine, Device Failure and the Plaintiff's Lawyer, in Proceedings
of the Second Annual AAMI/FDA Conference on Medical Device Regulation 54
(1975); Medical Device Amendments of 1975, Hearings Before the Subcommittee
on Health and the Environment of the House Committee on Interstate and
Foreign Commerce, Ser. No. 94-39, 94th Cong., 1st Sess., 271 (1975) (statement
of Anita Johnson, Public Citizen's Health Research Group) (arguing that
the pre-emption provision should not be included, but making no mention
of common law, and specifically discussing only a positive California enactment
regarding the safety of intrauterine contraceptive devices); Medical Devices
and Equipment Liability Avoidance (Frost & Sullivan pub. June 1977)
(comprehensive 2--volume, 600--page review of published medical device
product liability cases from 1910 to 1976, suggesting nowhere that MDA
had mooted or even altered the longstanding ability of plaintiffs to seek
and receive damages awards under state law).

14 As
the FDA Commissioner put it in 1982, "the 510(k) provision of the law is
a procompetition mechanism that permits firms to make and quickly market
me too versions of pre-1976 devices. The Congress apparently believed that
a firm whose device happened to be on the market before enactment of the
amendments and was never subject to preclearance by FDA should not enjoy
a lengthy monopoly at the expense of other firms and ultimately the consumer."
FDA Oversight: Medical Devices, Hearing before the Subcommittee on Oversight
and Investigations of the House Committee on Energy and Commerce, 97th
Cong., 2d Sess., 9 (1982). See also Kahan, Premarket Approval Versus Premarket
Notification: Different Routes to the Same Market, 39 Food Drug Cosm. L.
J. 510, 514-515 (1984); D. Kessler, S. Pape, & D. Sundwall, The Federal
Regulation of Medical Devices, 317 New England J. Med. 357, 359 (1987).

16 We
also note that the agency permits manufacturers of devices that have received
premarket approval to make certain labeling, quality control, and manufacturing
changes which would "enhance[] the safety of the device or the safety in
the use of the device" without prior FDA approval. See 21
CFR §§ 814.39(d)(1) and (2) (1995).

17 Some
GMP's include the duty to institute a "quality assurance program," §820.5,
to have an "adequate organizational structure," §820.20, to ensure
that personnel in contact with a device are "clean, healthy, and suitably
attired" where such matters are relevant to the device's safety, §820.25,
and to have buildings, environmental controls, and equipment of a quality
adequate to produce a safe product, see §§820.40, 820.46, 820.60.

18 FDA's
narrow understanding of the scope of §360k(a) is obvious from the
full text of the regulation, which provides, in relevant part:

%(d) State or local requirements are preempted only when the Food
and Drug Administration has established specific counterpart regulations
or there are other specific requirements applicable to a particular device
under the act, thereby making any existing divergent State or local requirements
applicable to the device different from, or in addition to, the specific
Food and Drug Administration requirements. There are other State or local
requirements that affect devices that are not preempted by section 521(a)
of the act because they are not `requirements applicable to a device' within
the meaning of section 521(a) of the act. The following are examples of
State or local requirements that are not regarded as preempted by section
521 of the act:

"(1) Section 521(a) does not preempt State or local requirements
of general applicability where the purpose of the requirement relates either
to other products in addition to devices (e.g., requirements such as general
electrical codes, and the Uniform Commercial Code (warranty of fitness)),
or to unfair trade practices in which the requirements are not limited
to devices.

"(2) Section 521(a) does not preempt State or local requirements
that are equal to, or substantially identical to, requirements imposed
by or under the act.

. . . . .

"(6)(i) Section 521(a) does not preempt State or local requirements
respecting general enforcement, e.g., requirements that State inspection
be permitted of factory records concerning all devices . . . .

"(ii) Generally, section 521(a) does not preempt a State or local
requirement prohibiting the manufacture of adulterated or misbranded devices.
Where, however, such a prohibition has the effect of establishing a substantive
requirement for a specific device, e.g., a specific labeling requirement,
then the prohibition [may] be preempted." 21
CFR § 808.1(d) (1995).

19 A
plurality of this Court concluded in Cipollone that a similar analysis
was required under the Public Health Cigarette Smoking Act of 1969. That
act pre-empted requirements and prohibitions based on smoking and health
"imposed under State law with respect to the advertising or promotion"
of cigarettes in packages that were labeled in conformity with the that
act. 505 U. S., at 515. We held that the petitioner's fraudulent misrepresentation
claims, including those based on allegedly false statements made in advertisements,
were not pre-empted because they were "predicated not on a duty `based
on smoking and health' but rather on a more general obligation--the duty
not to deceive." Id., at 528-529. The general common law duty "not
to make fraudulent statements" was not within the specific category of
requirements or prohibitions based on smoking and health imposed under
State law "with respect to the advertising or promotion" of cigarettes
that were pre-empted by the 1969 statute. Id., at 529.

If anything, the language of the MDA's pre-emption statute and
its counterpart regulations require an even more searching inquiry into
the relationship between the federal requirement and the state requirement
at issue than was true under the statute in Cipollone.